Regulation on Exceptional Use Authorization

Publication: pbbr
Author: Rita Roque de Pinho | Raquel Soares Lourenço
Date: 03 October 2023

The following regulations came into force on 15.09.2023, approved by Resolution no. 840/2023 of 31 August, of Infarmed's Board of Directors: Regulation on Exceptional Use Authorization (“EUA”) and the Regulation on Authorization of Marketing Medicines without Valid Authorization or Registration in Portugal (“WAR”) thus replacing the previous regulations on these matters.

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